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Promethazine | CAS No: 60-87-7 | GMP-certified suppliers
A medication that provides symptomatic relief for allergic conditions, nausea and vomiting, motion sickness, sedation needs, and cough or cold-related respiratory discomfort across key markets.
Therapeutic categories
Primary indications
- Promethazine tablets and suppositories are indicated to treat rhinitis, allergic conjunctivitis, allergic reactions to blood or plasma, dermographism, anaphylactic reactions, sedation, nausea, vomiting, pain, motion sickness, and allergic skin reactions
- Promethazine cough syrup with phenylephrine and codeine is indicated to relieve cough and upper respiratory symptoms, and nasal congestion associated with allergy or the common cold
Product Snapshot
- Promethazine is a small‑molecule antihistamine available in oral, injectable, topical, and rectal formulations
- It is used for allergic conditions, motion sickness, nausea and vomiting, cough and upper respiratory symptoms in combinations, and as a sedative
- It is approved in the US and Canada, with both approved and investigational statuses depending on the product form
Clinical Overview
Pharmacologically, promethazine is a first‑generation H1 receptor antagonist with additional antagonism at muscarinic, alpha‑adrenergic, post‑synaptic mesolimbic dopamine, and NMDA receptors. This multi‑receptor profile underlies its antihistaminic, antiemetic, sedative, and anticholinergic properties. Clinical effects generally persist for 4 to 6 hours, with some responses lasting up to 12 hours.
Promethazine’s mechanism of action in allergic disease is primarily through blockade of peripheral H1 receptors. Its antiemetic activity arises from combined histaminergic, dopaminergic, and muscarinic antagonism within the medullary vomiting center. Central sedative and anxiolytic effects are associated with muscarinic and NMDA receptor inhibition.
Absorption and distribution characteristics are consistent with a lipophilic, centrally acting phenothiazine. It undergoes hepatic metabolism and is reported as a substrate and inhibitor of multiple cytochrome P450 pathways, including CYP2D6 and CYP2C9, which may contribute to drug–drug interaction risk. Renal excretion accounts for a portion of elimination.
Safety considerations include CNS and respiratory depression, reduced seizure threshold, anticholinergic effects, and potential bone marrow depression. Additional risks include QT interval prolongation, photosensitivity, and heightened sedation when combined with other depressants. Formulations containing codeine require attention to opioid‑related risks and regional regulatory controls.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of phenothiazine‑related impurities, validated analytical methods, and compliance with pharmacopoeial specifications and applicable GMP standards.
Identification & chemistry
| Generic name | Promethazine |
|---|---|
| Molecule type | Small molecule |
| CAS | 60-87-7 |
| UNII | FF28EJQ494 |
| DrugBank ID | DB01069 |
Pharmacology
| Summary | Promethazine is a multi‑receptor antagonist whose primary activity is blockade of histamine H1 receptors, supporting its use in allergic conditions and related symptoms. Additional antagonism at muscarinic, dopaminergic, and alpha‑adrenergic receptors contributes to its effects on nausea, vomiting, motion-related symptoms, and sedation. Its broad receptor profile underlies central nervous system depressant and antiemetic pharmacodynamic themes. |
|---|---|
| Mechanism of action | Promethazine is a an antagonist of histamine H1, post-synaptic mesolimbic dopamine, alpha adrenergic, muscarinic, and NMDA receptors.The antihistamine action is used to treat allergic reactions.Antagonism of muscarinic and NMDA receptors contribute to its use as a sleep aid, as well as for anxiety and tension.Antagonism of histamine H1, muscarinic, and dopamine receptors in the medullary vomiting center make promethazine useful in the treatment of nausea and vomiting. |
| Pharmacodynamics | Promethazine is is a histamine H1 antagonist that can be used for it's ability to induce sedation, reduce pain, and treat allergic reactions.Promethazine's effects generally last 4-6h but can last up to 12h.Patients should be counselled regarding CNS and respiratory depression, reduce seizure threshold, and bone marrow depression. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Histamine H1 receptor | Humans | antagonist |
| Dopamine D2 receptor | Humans | antagonist |
| Muscarinic acetylcholine receptor M1 | Humans | antagonist |
ADME / PK
| Absorption | A 25mg dose of intramuscular promethazine reaches a C<sub>max</sub> of 22ng/mL.Intravenous promethazine reaches a C<sub>max</sub> of 10.0ng/mL, with a T<sub>max</sub> of 4-10h, and an AUC of 14,466ng\*h/mL.Oral promethazine is only 25% bioavailable due to first pass metabolism.Oral promethazine reaches a C<sub>max</sub> of 2.4-18.0ng/mL, with a T<sub>max</sub> of 1.5-3h, and an AUC of 11,511ng\*h/mL. |
|---|---|
| Half-life | The elimination half life of promethazine is approximately 12-15h. |
| Protein binding | Promethazine is 93% protein bound in serum,mostly to albumin. |
| Metabolism | Promethazine is predominantly metabolized to promethazine sulfoxide, and minorly to desmethylpromethazine and a hydroxy metabolite.Hydroxylation of promethazine is predominantly mediated by CYP2D6. |
| Route of elimination | An intravenous dose of promethazine is 0.64% eliminated in the urine as the unchanged parent drug, 0.02-2.02% in the urine as desmethylpromethazine, 10% in the urine as promethazine sulfoxide. |
| Volume of distribution | The volume of distribution of promethazine is approximately 970L or 30L/kg. |
| Clearance | The intravenous clearance of promethazine is approximately 1.14L/min.The renal clearance of promethazine is 5.9mL/min and the renal clearance of promethazine sulfoxide is 90.4mL/min. |
Formulation & handling
- Promethazine is a small‑molecule phenothiazine suitable for oral, parenteral, rectal, and topical formulations, with low aqueous solubility that may require solubilizers for liquid products.
- Parenteral solutions need careful pH control and dilution practices due to irritation potential and stability sensitivity in aqueous media.
- High lipophilicity (LogP ~4.3) supports conventional oral solid forms but may influence excipient selection for consistent dissolution performance.
Regulatory status
| Lifecycle | Patent‑protection details were not provided, but with the API already marketed in the United States and Canada—both mature, highly regulated markets—the product appears to be in a post‑launch, established phase. Its market position is likely shaped primarily by generic competition and formulary dynamics rather than remaining exclusivity. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Promethazine was originally developed by a single originator, but its patents expired long ago, and the market is now dominated by numerous generic manufacturers and repackagers. Branded and combination products have broad global availability, with established use in the US, Canada, and other regions. The mature patent status supports widespread existing generic competition across all major markets. |
|---|
Safety
| Toxicity | The intraperitoneal LD<sub>50</sub> in rats is 170mg/kg and in mice is 160mg/kg.The subcutaneous LD<sub>50</sub> in rats is 400mg/kg and in mice is 240mg/kg.The oral LD<sub>50</sub> in mice is 255mg/kg. Patients experiencing an overdose of promethazine may present with mild central nervous system and cardiovascular depression, hypotension, respiratory depression, unconciousness, hyperreflexia, hypertonia, ataxia, athetosis, extensor-plantar reflexes, convulsions, dry mouth, flushing, gastrointestinal symptoms, and fixed, dilated pupils.Treat overdoses with symptomatic and supportive treatment, which may include activated charcoal, sodium sulfate, magnesium sulfate, controlled ventilation, diazepam, intravenous fluids, vasopressors, norepinephrine, phenylephrine, anticholinergic antiparkinsonian agents, diphenhydramine, barbiturates, or oxygen. |
|---|
- Acute toxicity is moderate to high, with intraperitoneal LD50 values of 160–170 mg/kg in rodents and oral LD50 in mice of 255 mg/kg, indicating the need for controlled exposure during handling
- Overdose exposures are associated with CNS and cardiovascular depression, neuromuscular hyperactivity, respiratory compromise, and mydriasis, reflecting a broad pharmacodynamic toxicity profile
- Processing environments should account for the compound’s potential to elicit pronounced anticholinergic and sedative effects upon accidental exposure
Promethazine is a type of Antihistamines
Antihistamines are a vital subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) widely used in the treatment of allergies and allergic reactions. These compounds work by blocking the action of histamines, which are responsible for triggering allergic symptoms such as itching, sneezing, runny nose, and watery eyes.
Antihistamines can be classified into two main categories: first-generation and second-generation antihistamines. First-generation antihistamines, such as diphenhydramine and chlorpheniramine, have been in use for several decades. They are effective in relieving allergy symptoms but are associated with drowsiness and other side effects due to their ability to cross the blood-brain barrier.
On the other hand, second-generation antihistamines, including cetirizine, loratadine, and fexofenadine, offer similar allergy relief with fewer sedative effects. These newer antihistamines are preferred for their improved safety profiles, making them suitable for use during the day without causing significant drowsiness.
Antihistamines are available in various forms, including tablets, capsules, syrups, and topical creams. They are extensively used to manage conditions such as hay fever, hives, allergic rhinitis, and insect bites. Moreover, antihistamines may also be combined with decongestants or other medications to provide relief from nasal congestion and sinus symptoms.
As pharmaceutical APIs, antihistamines are produced through meticulous synthesis and manufacturing processes, adhering to strict quality standards. These APIs serve as the active components in various branded and generic pharmaceutical formulations, making them crucial in the pharmaceutical industry's production of allergy medications.
In conclusion, antihistamines are a significant subcategory of pharmaceutical APIs widely used for alleviating allergy symptoms. Their classification into first- and second-generation antihistamines offers options based on efficacy and sedative effects. By blocking histamines, antihistamines provide relief from common allergic reactions, making them essential in the development of effective allergy medications.
Promethazine (Antihistamines), classified under Central Nervous System Agents
Central Nervous System (CNS) Agents are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that specifically target the central nervous system. The CNS encompasses the brain and spinal cord, playing a vital role in regulating and controlling various bodily functions, including cognition, movement, emotions, and sensory perception. These agents are designed to interact with specific receptors, enzymes, or ion channels within the CNS to modulate neural activity and restore normal functioning.
CNS agents comprise a diverse range of pharmaceutical APIs, including analgesics, anesthetics, antipsychotics, sedatives, hypnotics, anti-epileptics, and antidepressants. Each subcategory addresses distinct neurological disorders and conditions. For instance, analgesics alleviate pain by targeting receptors in the brain and spinal cord, while antipsychotics are employed to manage psychosis symptoms in mental illnesses such as schizophrenia.
The development of CNS agents involves rigorous research, molecular modeling, and extensive clinical trials to ensure safety, efficacy, and specific target engagement. Pharmaceutical companies invest significant resources in identifying novel drug targets, synthesizing new compounds, and optimizing their pharmacological properties. These agents undergo rigorous regulatory evaluations and must adhere to stringent quality standards and guidelines.
Given the prevalence of CNS disorders globally, the market demand for effective CNS agents is substantial. The development of innovative CNS APIs not only improves patient outcomes but also provides valuable commercial opportunities for pharmaceutical companies. Continued advancements in CNS agent research and development hold the promise of groundbreaking therapies that can improve the quality of life for individuals affected by neurological conditions.
Promethazine API manufacturers & distributors
Compare qualified Promethazine API suppliers worldwide. We currently have 14 companies offering Promethazine API, with manufacturing taking place in 6 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| C.F.M. | Producer | Italy | Italy | CoA | 1 products |
| Emcure Pharma | Producer | India | India | CoA, USDMF | 80 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Harika Drugs | Producer | India | India | CoA, WC | 3 products |
| Ipca Labs. | Producer | India | India | CoA, GMP, USDMF, WC | 69 products |
| Iwaki Seiyaku | Producer | Japan | Japan | CoA, JDMF | 21 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Piramal Pharma Solutions | Producer | India | India | CoA, GMP, WC | 44 products |
| Sanofi | Producer | France | Unknown | CEP, CoA, FDA, GMP, JDMF, USDMF | 93 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Sigma-Aldrich | Producer | United States | Unknown | CoA, USDMF | 13 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
When sending a request, specify which Promethazine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Promethazine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Promethazine API
Sourcing
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Technical
What is Promethazine (CAS 60-87-7) used for?
Which therapeutic class does Promethazine fall into?
What conditions is Promethazine mainly prescribed for?
How does Promethazine work?
What should someone know about the safety or toxicity profile of Promethazine?
What are important formulation and handling considerations for Promethazine as an API?
Is Promethazine a small molecule?
Are there special stability concerns for oral Promethazine?
Regulatory
Where is Promethazine approved or in use globally?
Pharmaoffer
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